Healthy Volunteers
Conditions
Brief summary
Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.
Interventions
DRUGZanubrutinib
Administered as a tablet or capsule
Sponsors
BeiGene
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 18.0 and 32.0 kg/m\^2, inclusive * In good health, determined by no clinically significant findings from medical history, 12-lead ECGs, vital sign measurements, and clinical laboratory evaluations as assessed by the investigator or designee * Female participants must be of non-childbearing potential (surgically sterile or postmenopausal)
Exclusion criteria
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee * Evidence of any infections (bacterial, viral, fungal, parasitic, COVID-19) within 4 weeks prior to the first dose of study drug, as determined by the investigator or designee * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator or designee * History or presence of an abnormal ECG prior to the first dose of the study drug that, in the opinion of the investigator or designee, is clinically significant * Abnormal liver function tests, as defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin \>upper limit of normal (ULN) range * Positive hepatitis panel and/or positive human immunodeficiency virus test Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of the maximum observed plasma concentration (Tmax) | Predose and up to 48 hours postdose up to Day 10 |
| Apparent volume of distribution (Vz/F) | Predose and up to 48 hours postdose up to Day 10 |
| Maximum observed plasma concentration (Cmax) | Predose and up to 48 hours postdose up to Day 10 |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) | Predose and up to 48 hours postdose up to Day 10 |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) | Predose and up to 48 hours postdose up to Day 10 |
| Rate of decrease of concentration in the terminal phase (λz) | Predose and up to 48 hours postdose up to Day 10 |
| Apparent oral clearance (CL/F) | Predose and up to 48 hours postdose up to Day 10 |
| Apparent terminal elimination half-life (t1/2) | Predose and up to 48 hours postdose up to Day 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinically significant laboratory values | Up to 30 days after last dose; up to approximately 7 weeks | Laboratory values are based on hematology, clinical chemistry, and urinalysis test results |
| Number of participants with clinically significant electrocardiogram (ECG) results | Up to 30 days after last dose; up to approximately 7 weeks | — |
| Number of participants with clinically significant vital sign measurements | Up to 30 days after last dose; up to approximately 7 weeks | Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature |
| Number of participants with adverse events (AEs) | Up to 30 days after last dose; up to approximately 7 weeks | — |
Countries
United States
Outcome results
None listed